Class II · Moderate risk
Levofloxacin Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Levofloxacin Injection in 5% Dextrose
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
Affected NDCs
36000-0046-24
36000-0047-24
36000-0048-24
Compare with the code on your package — it is the most precise check available.
Drug: Levofloxacin
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 36000-046-24
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1215-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Levofloxacin recalls
See all
Class II · Moderate risk
Levofloxacin Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levofloxacin Injection 500mg/20 mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk
Levofloxacin Ophthalmic Solution 0.5%
CGMP Deviations:
Other recalls by Baxter Healthcare Corporation
All 2018 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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